NCT02485977

Brief Summary

The overall goal of this study is to evaluate agreement between cardiac MR parameters and well-established clinical and catheterization parameters of poor prognosis in patients with pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate myocardial disease in patients with pulmonary hypertension would be beneficial to society due to the potential to replace serial invasive cardiac catheterization procedures with a noninvasive imaging test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

June 26, 2015

Last Update Submit

December 10, 2018

Conditions

Keywords

Pulmonary hypertensionMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • MRI scar burden measured by T1 mapping

    1 hour

Study Arms (1)

Pulmonary Hypertension

Adult patients with pulmonary hypertension referred for cardiac catheterization in the PI institution

Device: Magnetic resonance Imaging

Interventions

MRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium

Pulmonary Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with pulmonary hypertension referred for cardiac catheterization at UCSF

You may qualify if:

  • Adult
  • Pulmonary hypertension

You may not qualify if:

  • Pacemaker
  • Renal dysfunction
  • Cochlear implant
  • Previous lung transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations